Lubricant formulations

ABSTRACT

A composition for lubricant formulations is disclosed. The composition may include hypochlorite, dimethicone, and an emulsifier for improvement of lubricity. Methods of making and using the lubricant formulations are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. Ser. No.16/671,707, filed Nov. 1, 2019, which is a continuation application ofU.S. Ser. No. 15/818,531, filed Nov. 20, 2017, which issued as U.S. Pat.No. 10,471,003 on Nov. 12, 2019, which is a divisional application ofU.S. Ser. No. 15/266,147, filed Sep. 15, 2016, which issued as U.S. Pat.No. 9,833,406 on Dec. 5, 2017, and which is a continuation applicationof U.S. Ser. No. 15/158,442, filed May 18, 2016, which issued as U.S.Pat. No. 9,474,768 on Oct. 25, 2016, the disclosures of which are herebyexpressly incorporated by reference in their entireties.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to lubricant compositionsincluding antimicrobial agents. More specifically, the presentdisclosure is related to personal lubricants having hypochlorite, oracids or salts thereof, a silicone polymer, and one or more emulsifiers.The disclosure also relates to methods of making and using thelubricant.

BACKGROUND

Lubricants are useful generally for providing lubricity to variousinstruments and/or parts of the body, thereby reducing friction. Forexample, medical or surgical lubricants are useful for providinglubrication for decreasing the discomfort to a patient during certainmedical and surgical procedures, including, for example, rectal orvaginal examinations. Personal lubricants function similarly, and can beused, for example, for intimate contact, by increasing lubricity andcomfort during sexual intimacy.

Personal lubricants are of various types, with each type havingdifferent advantages. Water-based lubricants are water-soluble, andgenerally include water and a cellulose or glycerin solution. Oil-basedlubricants are derived from either synthetic or natural oils, and caninclude, for example, a petroleum ingredient, such as petroleum jelly.Silicone-based lubricants are manufactured from synthetic chemicalcompounds, and do not contain water. Silicone-based lubricants arecommonly formulated with a silicone ingredient, such as dimethicone orother polymeric organosilicon compound. Additional lubricants includehybrid lubricants, which may be formulated with water and silicone.Certain lubricants also further include sensory enhancing agents, thatprovide, for example, a warming or cooling sensation, or that provide avariety of odors or flavors.

Lubricants can be used as a stand-alone product for use during sexualintimacy, or have been used in combination with other products, such aswith medical devices or with condoms, which facilitates penetration orinsertion of the product. For example, personal lubricants may be usedalone or in combination with condoms or other devices to improvelubrication and comfort during sexual intimacy. Surgical or medicallubricants or gels may be used for medical purposes such as speculuminsertion or introduction of a catheter, ultra sounds, or other medicaldevices.

Personal lubricants have been developed that prevent or stop thedevelopment of itching from the vagina or other body parts. For example,U.S. Pat. No. 6,114,398 describes a personal lubricant having ClO₂,which is effective for the prevention of itching by eliminating Candidaspecies.

Vaginal itching is a common complaint among women. Vaginal itchingprimarily originates from Candida albicans, a diploid fungus that growsas both a yeast and as a filamentous cell. C. albicans is the mostcommon and possibly the most important causative agent of human fungalinfections (Edmond, M. B., et al. 1999, Clin. Infect. Dis. 29:239-244).C. albicans is a major opportunistic pathogen of immunocompromisedhosts, including AIDS patients and patients undergoing chemotherapy,patients who have had tissue transplants, and patients with centralvenous catheters. Studies indicate that up to ninety percent of AIDSpatients suffer from oropharyngeal and esophageal candidiasis, in whichC. albicans is the major causative agent (Schmidt-Westhausen, A., etal., 1991, J. Oral Pathol. Med. 20:467-472). C. albicans is a commensalof human mucosal surfaces. C. albicans causes a wide variety of diseasesincluding oral thrush and disseminated candidiasis. Systemic fungalinfections have emerged as important causes of morbidity and mortalityin immunocompromised patients (e.g., as a result of AIDS, cancerchemotherapy, organ or bone marrow transplantation). In addition,hospital-related infections in patients not previously considered atrisk (e.g., patients in an intensive care unit) have become a cause ofmajor health concern. C. albicans is also the major fungus thatcolonizes medical implants, causing device-associated infections withhigh mortality. (Kojic E. M., Darouiche R. O.: Candida Infections ofMedical Devices. Clin Microbiol Rev 2004, 17:255-267; Nobile et al.,Critical Role of Bcrl-dependent Adhesins in C. albicans BiofilmFormation In Vitro and In Vivo. PLoS Pathog. 2006, 2: e63). Infectionsinvolving medical devices are notoriously difficult to eliminate andgenerally necessitate removal of the device. C. albicans colonizes thesurfaces of catheters, prostheses, and epithelia, forming biofilms thatare extremely resistant to anti-fungal drugs. Mature C. albicansbiofilms show a complex three-dimensional architecture with extensivespatial heterogeneity, and consist of a dense network of yeast, hyphaeand pseudo hyphae encased within a matrix of exopolymeric material.

SUMMARY

The present disclosure describes lubricant formulations and compositionshaving hypochlorite, or acids and salts thereof, a silicone polymer, andan emulsifier. Also described are methods of making and using thelubricant formulations.

In some embodiments is provided a lubricant having hypochlorite, anemulsifier, and a silicone polymer. In some embodiments, the siliconepolymer is dimethicone.

In some embodiments is provided a personal lubricant includinghypochlorite or acids or salts thereof, and a silicone polymer. In someembodiments, the hypochlorite is hypochlorous acid (HClO). In someembodiments, the hypochlorite is a hypochlorite salt, such as NaClO,KClO, or Ca(ClO)₂. In some embodiments, the silicone polymer is apolymeric organosilicon compound. In some embodiments, as the polymericorganosilicon compound is dimethicone.

In some embodiments, the lubricant composition further includes, forexample, sodium magnesium silicate, sodium phosphate monobasic, water,buffer, sodium chloride, or combinations thereof

In some embodiments, the lubricant includes hypochlorite. In someembodiments, the hypochlorite is a salt or acid of hypochlorite, or ahypochlorite solution. In some embodiments, a final concentration ofhypochlorite in the lubricant is about 10, 15, 20, 25, 30, 35, 40, 45,50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200, 250, or300 ppm or within a range defined by any two of the aforementionedamounts. In some embodiments, the final concentration of hypochlorite inthe lubricant is about 50 to 100 ppm. In some embodiments, the finalconcentration of hypochlorite in the lubricant is about 75 ppm.

In some embodiments, the emulsifier is sodium phosphate. In someembodiments, the emulsifier is present in the lubricant in an amount ofabout 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%, or 2.5% w/v orwithin a range defined by any two of the aforementioned amounts.. Insome embodiments, the emulsifier is present in the lubricant in anamount of about 0.2% w/v.

In some embodiments, the silicone polymer is dimethicone. In someembodiments, the silicone polymer is present in the lubricant in anamount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%, or 50% w/v orwithin a range defined by any two of the aforementioned amounts.. Insome embodiments, the silicone polymer is present in the lubricant in anamount of about 10% w/v.

In some embodiments, the lubricant further includes sodium magnesiumsilicate, water, or buffer or combinations thereof. In some embodiments,the sodium magnesium silicate is present in the lubricant in an amountof about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%,4.5%, 5%, 6%, 7%, 10%, or 15% w/v or within a range defined by any twoof the aforementioned amounts. In some embodiments, the sodium magnesiumsilicate is present in the lubricant in an amount of about 3.25% w/v. Insome embodiments, the water and/or buffer makes up the balance of thelubricant, and includes about 20%, 30%, 40%, 45%, 50%, 55%, 56%, 57%,58%, 59%, 60%, 61%, 61.55%, 62%, 62.5%, 63%, 65%, 70%, 75%, 80%, or 90%w/v or within a range defined by any two of the aforementioned amounts.

In some embodiments is provided a lubricant, wherein the lubricantincludes a hypochlorite solution in an amount of about 25% w/v. In someembodiments, the hypochlorite solution includes about 300 ppmhypochlorite, dimethicone in an amount of about 10% w/v, sodiumphosphate in an amount of about 0.2% w/v. In some embodiments, thelubricant further includes sodium magnesium silicate in an amount ofabout 3.25% w/v and water and/or buffer in an amount of about 61.55%w/v. In some embodiments, the water and/or buffer makes up all orsubstantially all of the balance of the lubricant.

In some embodiments is provided a lubricant including about 75 ppmhypochlorite, about 10% w/v dimethicone, and optionally 0.2% w/v sodiumphosphate. In some embodiments, the lubricant further includes sodiummagnesium silicate and water. In some embodiments, the personallubricant may further include a buffer.

In some embodiments, the lubricant as disclosed herein is characterizedin having an osmolality by vapor pressure of about 10, 20, 30, 35, 36,37, 38, 39, 40, 41, 42, 43, 44, 45, 46 ,47, 48, 49, 50, 55, 60, 70, 80,90, or 100 mmol/kg, or within a range defined by any two of theaforementioned amounts. In some embodiments, the osmolality by vaporpressure is about 38 mmol/kg. In some embodiments, the osmolality byvapor pressure is about 49 mmol/kg. In some embodiments, the lubricantis characterized in having an osmolality by freezing point depression ofabout 10, 15, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45,50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 65, 70, 80, 90, or 100mOsm/kg, or within a range defined by any two of the aforementionedamounts. In some embodiments, the osmolality by freezing pointdepression is about 22 mOsm/kg. In some embodiments, the osmolality byfreezing point depression is about 54 mOsm/kg.

In some embodiments is provided a method of making the lubricantformulation. In some embodiments, the method includes providinghypochlorite. In some embodiments, the hypochlorite is provided as ahypochlorite acid or salt. In some embodiments, the hypochlorite isprovided as a hypochlorite solution. In some embodiments, the method ofmaking the lubricant includes providing hypochlorite in an amount ofabout 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85,90, 95, 100, 120, 150, 175, 200, 250, or 300 ppm or within a rangedefined by any two of the aforementioned amounts. In some embodiments,hypochlorite is provided in an amount of about 50 to 100 ppm. In someembodiments, the hypochlorite is provided in an amount of about 75 ppm.

In some embodiments, the method of making the lubricant includesproviding a hypochlorite solution. In some embodiments, the hypochloritesolution is prepared from hypochlorite acids or salts. In someembodiments, the hypochlorite salt is sodium hypochlorite. In someembodiments, the hypochlorite solution is prepared from sodium chloride.In some embodiments, the method includes running sodium chloridesolution through electrolysis. In some embodiments, the sodium chloridesolution is provided in an amount of about 0.1%, 0.15%, 0.2%, 0.25%,0.3%, 0.35%, or 0.4% w/v. In some embodiments, the sodium chloride is0.28%, and the resulting hypochlorite solution is about 300 ppm. In someembodiments, the method of making the lubricant includes diluting thehypochlorite solution to provide hypochlorite in an amount of about 10,15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100,120, 150, 175, 200, 250, or 300 ppm or within a range defined by any twoof the aforementioned amounts. In some embodiments, hypochlorite isdiluted to an amount of about 50 to 100 ppm. In some embodiments, thehypochlorite is diluted to an amount of about 75 ppm.

In some embodiments, the method of making the lubricant further includesproviding a silicone polymer. In some embodiments, the silicone polymeris dimethicone. In some embodiments, the silicone polymer is provided inan amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%, or 50% w/v, orwithin a range defined by any two of the aforementioned amounts. In someembodiments, the silicone polymer is provided in an amount of about 10%w/v.

In some embodiments, the method further includes providing anemulsifier. In some embodiments, the emulsifier is sodium phosphate. Insome embodiments, the emulsifier is provided in an amount of about0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%, or 2.5% w/v or withina range defined by any two of the aforementioned amounts.. In someembodiments, the emulsifier is provided in an amount of about 0.2% w/v.

In some embodiments, the method of making the lubricant further includesproviding sodium magnesium silicate, water, or buffer or combinationsthereof. In some embodiments, the sodium magnesium silicate is providedin an amount of about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%, 2.5%, 3%,3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, or 15% w/v or within a range defined byany two of the aforementioned amounts. In some embodiments, the sodiummagnesium silicate is provided in an amount of about 3.25% w/v. In someembodiments, the water and/or buffer is provided in an amount to make upall or substantially all of the balance of the lubricant, and isprovided in an amount of about 20%, 30%, 40%, 45%, 50%, 55%, 56%, 57%,58%, 59%, 60%, 61%, 61.55%, 62%, 62.5%, 63%, 65%, 70%, 75%, 80%, 90% or95% w/v or within a range defined by any two of the aforementionedamounts.

In some embodiments is provided a method of using a lubricant. In someembodiments, the method includes providing the lubricant and applyingthe lubricant. In some embodiments, the lubricant is provided as aready-to-use formulation that includes hypochlorite or acids or saltsthereof, silicone polymer, and an emulsifier, and further may includesodium magnesium silicate, water, or buffer. In some embodiments, thelubricant is provided in portions, and further additions and/or mixingis required prior to use. In some embodiments, the lubricant is appliedin the penile or vaginal regions. In some embodiments, the lubricant isapplied on a condom or other device. In some embodiments, the lubricantis applied multiple times daily, once daily, multiple times weekly, onceweekly, multiple times monthly, or once monthly, or within a time framedefined by any two of the aforementioned time frames. In someembodiments, the lubricant is applied liberally. In some embodiments,the lubricant is applied meagerly.

In some embodiments is provided a method of using a lubricant forincreasing comfort and lubricity. In some embodiments, the increase incomfort and lubricity is experienced during sexual intimacy. In someembodiments, the lubricant is used alone or in combination with condomsor other devices.

In some embodiments is provided a method of using a lubricant for thecessation, amelioration, prevention, or inhibition of the development ofitching from the vagina or other body parts by eliminating microbialcausing infections.

In some embodiments is provided a method of using the lubricantcomposition to stop a fungal infection. In some embodiments, the fungalinfection is caused by a yeast of the Candida genus. In one embodiment,the yeast is of the Candida albicans species. In other embodiments, theCandida yeast may be of the Candida dubliniensis, Candida parapsilosis,Candida tropicalis, Candida kefyr, Candida guilliermondii, Candidainconspicua, Candida famata, Candida glabrata, Candida krusei, Candidalusitaniae, or other Candida species, or combinations thereof. In someembodiments, the lubricant composition is used to stop a viralinfection.

DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented herein. It will be readily understood that the aspects of thepresent disclosure, as generally described herein, and illustrated inthe Figures, can be arranged, substituted, combined, separated, anddesigned in a wide variety of different configurations, all of which areexplicitly contemplated herein.

Lubricants, including personal lubricants are described herein that areuseful for increasing lubricity. In some embodiments, the personallubricant is useful for penile and/or vaginal application for increasinglubricity and for enhancing the ease and comfort of sexual intimacy, andfor supplementing the body's natural lubrication. In some embodiment,the personal lubricant may be used alone or in combination with condomsor other devices to improve lubrication and comfort during sexualintimacy. In some embodiments, lubricants may be useful for treating,ameliorating, or reducing the itchiness associated with fungal, viral,or other skin conditions. In some embodiments, the personal lubricant isa hybrid-based lubricant that includes water and silicone. In someembodiments described herein are methods of making and using thelubricant formulations.

Definitions

Unless defined otherwise, technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the present disclosure belongs. For purposes of thepresent disclosure, the following terms are defined below.

By “about” is meant a quantity, level, value, number, frequency,percentage, dimension, size, amount, weight or length that varies by asmuch as 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1% to a referencequantity, level, value, number, frequency, percentage, dimension, size,amount, weight or length.

Throughout this specification, unless the context requires otherwise,the words “comprise,” “comprises,” and “comprising” will be understoodto imply the inclusion of a stated step or element or group of steps orelements but not the exclusion of any other step or element or group ofsteps or elements.

By “consisting of” is meant including, and limited to, whatever followsthe phrase “consisting of” Thus, the phrase “consisting of” indicatesthat the listed elements are required or mandatory, and that no otherelements may be present. By “consisting essentially of” is meantincluding any elements listed after the phrase, and limited to otherelements that do not interfere with or contribute to the activity oraction specified in the disclosure for the listed elements. Thus, thephrase “consisting essentially of” indicates that the listed elementsare required or mandatory, but that other elements are optional and mayor may not be present depending upon whether or not they materiallyaffect the activity or action of the listed elements.

In some embodiments, the “purity” of any given agent (for example,dimethicone or hypochlorous acid) in a composition may be specificallydefined. For instance, certain compositions may include, for example, anagent that is at least 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99,or 100% pure, including all decimals in between, as measured, forexample and by no means limiting, by analytical chemistry techniques.

As used herein, the terms “function” and “functional” and the like referto a biological, chemical, mechanical, or therapeutic function.

“Hypochlorous acid”, as used herein, refers to a weak acid having thechemical formula HClO. Hypochlorous acid is also known as chloric (I)acid, chloranol, or hydroxidochlorine. Salts of hypochlorite are alsoreferred to herein and can include sodium hypochlorite (NaClO), calciumhypochlorite (Ca(ClO)₂), or potassium hypochlorite (KClO). As describedherein, hypochlorous acid and hypochlorite are used as killing agents,skin cleansing agents, disinfectants, antibacterial agents, sanitizers,and/or preservatives. Hypochlorite, or acids and salts thereof, may beused in the lubricants and personal lubricants of the present inventionat an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%,or greater w/v%, or within a range defined by any two of theaforementioned amounts. In some embodiments, the w/v% of hypochlorite oran acid or salt thereof is about 25% w/v. In some embodiments, thehypochlorite salt or hypochlorous acid is added directly to a personallubricant, wherein the final amount of hypochlorite is less than,greater than, or equal to about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55,60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200, 300 ppm orwithin a range defined by any two of the aforementioned amounts. In someembodiments, the amount of hypochlorite in the lubricant is betweenabout 50 to about 100 ppm. In some embodiments, the amount ofhypochlorite in the lubricant is about 75 ppm.

In some embodiments, the hypochlorite is added to the lubricant as ahypochlorite solution. In some embodiments, the hypochlorite solution isprepared from hypochlorite salt or hypochlorous acid. In someembodiments, the solution of hypochlorite is prepared by passing asodium chloride solution through electrolysis. In some embodiments, thesodium chloride solution is a 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%,0.4% or greater w/v% or within a range defined by any two of theaforementioned amounts. In some embodiments, the sodium chloride is0.28%, and the resulting hypochlorite solution is 300 ppm. In someembodiments, the hypochlorite solution is added to the personallubricant in an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 25%, 30%,40%, 50% or greater w/v%, or within a range defined by any two of theaforementioned amounts. In some embodiments, the solution includes, forexample, about 300 ppm hypochlorite is added to a personal lubricant inan amount of about 25% w/v.

As used herein, silicone polymers include dimethicone, which is alsoknown as polydimethylsiloxane (PDMS), dimethylpolysiloxane, E900, orpolymerized siloxane and has the chemical formula ofCH₃[Si(CH₃)₂O],Si(CH₃)₃ where n is the number of repeating monomer[Si(CH₃)₂] units. Silicone polymers are used as an inert slip agent orlubricant. The silicone polymer may be used in the lubricant or personallubricant in an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%,50%, or greater w/v%, or in an amount within any two of theaforementioned values or between a range defined by these values. Insome embodiments, the amount of silicone polymer is about 10% w/v.

As used herein, the term “sodium magnesium silicate” refers to asilicate of sodium and magnesium and is a synthetic silicate clay,having magnesium and sodium silicate. It is used as a binder and bulkingagent in cosmetics and personal care products, in part because of itsability to absorb water. It is also used in the creation of concrete.Sodium magnesium silicate is effective in slowing the decomposition offormulas, and can prevent premature darkening of the cosmeticcomposition and prevent premature development of a foul odor, therebyimproving the shelf life of cosmetic compositions. In some embodiments,the sodium magnesium silicate is Laponite. As used herein, sodiummagnesium silicate is useful as a gelling agent or rheology modifier.Sodium magnesium silicate may be used in the lubricant or personallubricant in an amount of about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%,2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, 15%, or greater w/v%, or inan amount within any two of the aforementioned values or between a rangedefined by these values. In some embodiments, the amount of sodiummagnesium silicate is about 3.25% w/v.

As used herein, the term “sodium phosphate monobasic” refers to thechemical formula of NaH₂PO₄, an inorganic compound of sodium withdihydrogen phosphate. Sodium phosphate monobasic is also referred to assodium dihydrogen phosphate, sodium phosphate, monosodium phosphate,sodium biphosphate, acid sodium phosphate, monosodium orthophosphate, orprimary sodium phosphate. As described herein, it may be used foradjustment of pH, as a thickening agent, or as an emulsifier. Sodiumphosphate monobasic may be used in the lubricant or personal lubricantin an amount of about 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%,2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, 15%, or greater w/v%, or inan amount within any two of the aforementioned values. In someembodiments, the amount of sodium phosphate is about 3.25% w/v.

The personal lubricants described herein may further include an additiveknown in the art can be included. Exemplary additives includeemollients, moisturizers, humectants, pigments, dyes, pearlescentcompounds, nacreous pigments, bismuth oxychloride coated mica, titaniumdioxide coated mica, colorants, fragrances, biocides, preservatives,alpha hydroxy acids, antioxidants, anti-microbial agents, anti-fungalagents, antiperspirant agents, exfoliants, hormones, enzymes, medicinalcompounds, vitamins, salts, electrolytes, alcohols, polyols,polypropylene glycol, polyisobutene, polyoxyethylene, behenic acid,behenyl, sugar-alcohols, absorbing agents for ultraviolet radiation,botanical extracts, surfactants, silicone oils, organic oils, waxes,alkaline or acidic or buffering agents, film formers, thickening agents,hyaluronic acid, fumed silica, hydrated silica, talc, kaolin, starch,modified starch, mica, nylon, clay, bentonite, organo-modified clays andcombinations thereof.

In some embodiments, the personal lubricant described herein ischaracterized in having an osmolality by vapor pressure of about 10, 20,30, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46 ,47, 48, 49, 50, 55,60, 70, 80, 90, or 100 mmol/kg, or within a range defined by any two ofthe aforementioned amounts. In some embodiments, the osmolality by vaporpressure is about 38 mmol/kg. In some embodiments, the osmolality byvapor pressure is about 49 mmol/kg. In some embodiments, the lubricantis characterized in having an osmolality by freezing point depression ofabout 10, 15, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45,50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 65, 70, 80, 90, or 100mOsm/kg, or within a range defined by any two of the aforementionedamounts. In some embodiments, the osmolality by freezing pointdepression is about 22 mOsm/kg. In some embodiments, the osmolality byfreezing point depression is about 54 mOsm/kg.

In some embodiments is provided a method of making the lubricantformulation. In some embodiments, the method includes providinghypochlorite. In some embodiments, the hypochlorite is provided as ahypochlorite acid or salt. In some embodiments, the hypochlorite isprovided as a hypochlorite solution. In some embodiments, the method ofmaking the lubricant includes providing hypochlorite in an amount ofabout 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85,90, 95, 100, 120, 150, 175, 200, 250, or 300 ppm or within a rangedefined by any two of the aforementioned amounts. In some embodiments,hypochlorite is provided in an amount of about 50 to 100 ppm. In someembodiments, the hypochlorite is provided in an amount of about 75 ppm.

In some embodiments, the method of making the lubricant includesproviding a hypochlorite solution. In some embodiments, the hypochloritesolution is prepared from hypochlorite acids or salts. In someembodiments, the hypochlorite salt is sodium hypochlorite. In someembodiments, the hypochlorite solution is prepared from sodium chloride.In some embodiments, the method includes running sodium chloridesolution through electrolysis. In some embodiments, the sodium chloridesolution is provided in an amount of about 0.1%, 0.15%, 0.2%, 0.25%,0.3%, 0.35%, or 0.4% w/v. In some embodiments, the sodium chloride is0.28%, and the resulting hypochlorite solution is about 300 ppm. In someembodiments, the method of making the lubricant includes diluting thehypochlorite solution to provide hypochlorite in an amount of about 10,15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100,120, 150, 175, 200, 250, or 300 ppm or within a range defined by any twoof the aforementioned amounts. In some embodiments, hypochlorite isprovided in an amount of about 50 to 100 ppm. In some embodiments, thehypochlorite is provided in an amount of about 75 ppm.

In some embodiments, the method of making the lubricant further includesproviding a silicone polymer. In some embodiments, the silicone polymeris dimethicone. In some embodiments, the silicone polymer is provided inan amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%, or 50% w/v, orwithin a range defined by any two of the aforementioned amounts. In someembodiments, the silicone polymer is provided in an amount of about 10%w/v.

In some embodiments, the method further includes providing anemulsifier. In some embodiments, the emulsifier is sodium phosphate. Insome embodiments, the emulsifier is provided in an amount of about0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 1.5%, 2%, or 2.5% w/v or withina range defined by any two of the aforementioned amounts.. In someembodiments, the emulsifier is provided in an amount of about 0.2% w/v.

In some embodiments, the method of making the lubricant further includesproviding sodium magnesium silicate, water, or buffer or combinationsthereof. In some embodiments, the sodium magnesium silicate is providedin an amount of about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%, 2.5%, 3%,3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, or 15% w/v or within a range defined byany two of the aforementioned amounts. In some embodiments, the sodiummagnesium silicate is provided in an amount of about 3.25% w/v. In someembodiments, the water and/or buffer is provided in an amount to make upthe balance of the lubricant, and is provided in an amount of about 20%,30%, 40%, 45%, 50%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 61.55%, 62%,62.5%, 63%, 65%, 70%, 75%, 80%, or 90% w/v or within a range defined byany two of the aforementioned amounts.

As used herein, the term “buffer” refers to a buffering agent and isused for balancing the pH and/or osmolality of the lubricant. Examplesof a buffer for use herein include, for example, salts of phosphates,borates, citrates, ascorbates, carbonates, bicarbonates, TRIS, HEPES,sodium ions, potassium ions, chloride ions, bicarbonate ions, glucose,sucrose, peptides, proteins, a combination or mixture thereof or otheragents that are chemically, functionally, or physiologically equivalentor similar. The lubricant compositions provided herein have an optimumpH and viscosity, with an osmolality that is hypo-osmotic, having anosmolality by vapor pressure of about 10, 20, 30, 35, 36, 37, 38, 39,40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 70, 80, 90, or 100mmol/kg, or within a range defined by any two of the aforementionedamounts. In some embodiments, the osmolality by vapor pressure is about38 mmol/kg. In some embodiments, the osmolality by vapor pressure isabout 49 mmol/kg. In some embodiments, the lubricant is characterized inhaving an osmolality by freezing point depression of about 10, 15, 20,21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 51, 52, 53, 54,55, 56, 57, 58, 59, 60, 65, 70, 80, 90, or 100 mOsm/kg, or within arange defined by any two of the aforementioned amounts. In someembodiments, the osmolality by freezing point depression is about 22mOsm/kg. In some embodiments, the osmolality by freezing pointdepression is about 54 mOsm/kg. The osmolality of the lubricant can bedetermined by vapor pressure osmometry or freezing point osmometry.

In some embodiments is provided a method of using a lubricant. In someembodiments, the method includes providing the lubricant and applyingthe lubricant. In some embodiments, the lubricant is provided as aready-to-use formulation that includes hypochlorite or acids or saltsthereof, silicone polymer, and an emulsifier, and further may includesodium magnesium silicate, water, or buffer. In some embodiments, thelubricant is provided in portions, and further additions and/or mixingis required prior to use. In some embodiments, the lubricant is appliedin the penile or vaginal regions. In some embodiments, the lubricant isapplied on a condom or other device. In some embodiments, the lubricantis applied multiple times daily, once daily, multiple times weekly, onceweekly, multiple times monthly, or once monthly, or within a time framedefined by any two of the aforementioned time frames. In someembodiments, the lubricant is applied liberally. In some embodiments,the lubricant is applied meagerly.

In some embodiments, the personal lubricant as disclosed herein isuseful for improving lubrication and comfort during sexual intimacy. Insome embodiments, the personal lubricant described herein is a hybridlubricant that includes both water and silicone. In some embodiments,the personal lubricant includes hypochlorite, or a salt or acid thereof,dimethicone, and an emulsifier. In some embodiments, the personallubricant includes water and/or buffer, hypochlorous acid solution,dimethicone, sodium magnesium silicate, and sodium phosphate.

In some embodiments is provided a method of using a lubricant for thecessation, amelioration, prevention, or inhibition of the development ofitching from the vagina or other body parts by eliminating microbialcausing infections.

In some embodiments, the personal lubricant is useful for alleviatingdiscomfort in a subject having inflammation or discomfort in the vaginalor vulvovaginal area. Symptoms can include but are not limited toirritation and/or itching of the genital area, inflammation of thevaginal or perineal area or pain. Causes can include but are not limitedto disruption of the healthy microbiota, infections, yeast, bacteria orviruses. Pathogens that can cause irritation can include but are notlimited to Candida, Gardnerella, gonorrhea, chlamydia, Mycoplasma,herpes, Campylobacter, or Trichomonas vaginalis. Irritation can alsooccur due to effects of diabetes, birth control, bad diet, tightclothing, use of antibiotics, hormonal vaginitis due to post-menopauseor postpartum, or loss of estrogen. Irritants also originate fromcondoms, spermicides, soaps, perfumes, and lubricants. Loss of estrogenor hormonal vaginitis can also lead to dryness of tissues.

In some embodiments is provided a method of using the lubricantcomposition to stop a fungal infection. In some embodiments, the fungalinfection is caused by a yeast of the Candida genus. In one embodiment,the yeast is of the Candida albicans species. In other embodiments, theCandida yeast may be of the Candida dubliniensis, Candida parapsilosis,Candida tropicalis, Candida kefyr, Candida guilliermondii, Candidainconspicua, Candida famata, Candida glabrata, Candida krusei, Candidalusitaniae, or other Candida species, or combinations thereof. In someembodiments, the lubricant composition is used to stop a viralinfection.

In some embodiments, the lubricant as disclosed herein is useful as amedical or surgical lubricant for use with medical instruments forinsertion, penetration, or introduction of a catheter, ultra sound, orother medical device into a subject.

The invention is generally disclosed herein using affirmative languageto describe the numerous embodiments. The invention also includesembodiments in which subject matter is excluded, in full or in part,such as substances or materials, method steps and conditions, protocols,or procedures.

EXAMPLES

Some aspects of the embodiments discussed above are disclosed in furtherdetail in the following examples, which are not in any way intended tolimit the scope of the present disclosure. Those in the art willappreciate that many other embodiments also fall within the scope of theinvention, as it is described herein above and in the claims.

Example 1 Preparation of Personal Lubricant Formulations

The following example demonstrates the method of preparing the personallubricant and various compositions or formulations thereof

A personal lubricant was prepared with the ingredients as provided inTable 1. Hypochlorite or a salt or acid thereof was added to water,dimethicone, sodium magnesium silicate, and sodium phosphate in thepreparation of a personal lubricant formulation PL-10.

TABLE 1 Personal Lubricant 10 (PL-10) Formulation Ingredient QuantityWater and/or buffer balance Hypochlorite 75 ppm Dimethicone 10% w/vSodium Magnesium Silicate 3.25% w/v Sodium Phosphate 0.2% w/v

The personal lubricant formulation described in Table 1 was tested onvarious organisms associated with sexually transmitted diseases todetermine the efficacy of inhibiting, eradication, or reducing theorganismal population. Various microbial pathogens were tested,including human immunodeficiency virus (HIV), Herpes simplex virus(HSV), Hepatitis B virus (HBV), Chlamydia trachomatis, and Neisseriagonorrhoeae. These studies are described in detail in the followingexamples.

Alternative Preparation Example 1

A personal lubricant having 25% of a 220 ppm hypochlorite solution wasadded to 10% w/v dimethicone, with 3.25% w/v sodium magnesium silicateand 0.2% sodium phosphate, with the balance of 61.55% water. Thehypochlorite solution was prepared by passing 0.28% sodium chloridethrough electrolysis to provide a 220 ppm hypochlorite solution.

Example 2 Efficacy of Personal Lubricant Against HIV-1 in Suspension

The following example shows the results of the efficacy of the personallubricant against HIV-1 in suspension.

HIV-1 was evaluated in a virucidal suspension assay. The test medium wasRoswell Park Memorial Institute-1640 (RPMI-1640) medium supplementedwith 15% (v/v) heat-inactivated fetal bovine serum (FBS). The medium wasalso supplemented with 2.0 mM L-glutamine and 50 μg/mL gentamicin. Thesuspension containing HIV-1 was exposed to the personal lubricantformulation. At a pre-determined exposure time, an aliquot was removed,neutralized by serial dilution, and assayed for the presence of virus.The virus controls, cytotoxicity control, and neutralization controlwere assays in parallel. Antiviral properties of the personal lubricantwere evaluated and compared at the specified concentrations and timeintervals.

HIV-1 strain HTLV MB was exposed to a personal lubricant formulation,PL-10, for an exposure time of either 5 minutes or 10 minutes at atemperature of 20.0° C. in the presence of a 5% FBS organic soil load.PL-10 demonstrated a greater than 99.99% reduction in viral titerfollowing 5 and 10 minute exposure times to HIV-1, as compared to thetiter of the corresponding virus control. The 50% tissue cultureinfective dose (TCID₅₀)/200 μL, a measure of infectious virus titer, wasless than 10^(2.50) at both 5 and 10 minutes. Table 2 summarizes theeffects of exposure of the personal lubricant to a suspension of HIV-1.The cytotoxicity and neutralization control results are presented inTable 3. MT-2 (human T cell leukemia cells) were used as indicator cellcultures.

TABLE 2 Effects of PL-10 Against HIV-1 in Suspension Virus ControlHIV-1 + PL-10 5 minute 10 minute 5 minute 10 minute Dilution exposureexposure exposure exposure Cell Control 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 010⁻² + + + + + + + + T T T T T T T T 10⁻³ + + + + + + + + 0 0 0 0 0 0 00 10⁻⁴ + + + + + + + + 0 0 0 0 0 0 0 0 10⁻⁵ + + + + + + + + 0 0 0 0 0 00 0 10⁻⁶ + + + + + + + + 0 0 0 0 0 0 0 0 10⁻⁷ 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 TCID₅₀/200 μL 10^(6.50) 10^(6.50) ≤10^(2.50) ≤10^(2.50) PercentReduction ≥99.99% ≥99.99% Log Reduction ≥4.00 log₁₀ ≥4.00 log₁₀ (+) =positive test for the presence of test virus (0) = no test virusrecovered and/or no cytotoxicity present (T) = cytotoxicity present

TABLE 3 PL-10 Cytotoxicity and Neutralization Results for HIV-1Cytotoxicity Control Neutralization Control Dilution PL-10 HIV-1 + PL-10Cell Control 0 0 0 0 0 0 0 0 10⁻² T T T T T T T T 10⁻³ 0 0 0 0 + + + +10⁻⁴ 0 0 0 0 + + + + 10⁻⁵ 0 0 0 0 + + + + 10⁻⁶ 0 0 0 0 + + + + 10⁻⁷ 0 00 0 + + + + TCID₅₀/200 μL 10^(2.50) *Neutralized at ≤2.50 Log₁₀ (+) =positive test for the presence of test virus (0) = no test virusrecovered and/or no cytotoxicity present (T) = cytotoxicity present*Neutralization control reported as TCID₅₀/250 μL

Example 3 Efficacy of Personal Lubricant Against HSV-2 in Suspension

The following example shows the results of the efficacy of the personallubricant against HSV-2 in suspension.

HSV-2 was evaluated in a virucidal suspension assay. The test medium wasminimum essential medium (MEM) supplemented with 5% (v/v)heat-inactivated FBS. The medium was also supplemented with 100 units/mLpenicillin, 10 μg/mL gentamicin, and 2.5 μg/mL amphotericin B. HSV-2 wasexposed to the personal lubricant formulation. At a pre-determinedexposure time, an aliquot was removed, neutralized by serial dilution,and assayed for the presence of virus. The virus controls, cytotoxicitycontrol, and neutralization control were assays in parallel. Antiviralproperties of the personal lubricant were evaluated and compared at thespecified concentrations and time intervals.

HSV-2, ATCC VR-734, Strain G was exposed to a personal lubricantformulation, PL-10. The exposure time was of either 5 minutes or 10minutes at a temperature of 21.0° C. in the presence of a 5% FBS organicsoil load. PL-10 demonstrated a greater than 99.9997% reduction in viraltiter following 5 minute exposure time and a greater than 99.998%reduction in viral titer following a 10 minute exposure time to HSV-2,as compared to the titer of the corresponding virus control. The logreductions in viral titer were greater than 5.50 log₁₀ and greater than4.75 log₁₀, respectively. Table 4 summarizes the effects of exposure ofthe personal lubricant to a suspension of HSV-2. The cytotoxicity andneutralization control results are presented in Table 5. Vero cells wereused as indicator cell cultures.

TABLE 4 Effects of PL-10 Against HSV-2 in Suspension Virus ControlHSV-2 + PL-10 5 minute 10 minute 5 minute 10 minute Dilution exposureexposure exposure exposure Cell Control 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 010⁻² + + + + + + + + 0 0 0 0 0 0 0 0 10⁻³ + + + + + + + + 0 0 0 0 0 0 00 10⁻⁴ + + + + + + + + 0 0 0 0 0 0 0 0 10⁻⁵ + + + + + + + + 0 0 0 0 0 00 0 10⁻⁶ + + + + + 0 + + 0 0 0 0 0 0 0 0 10⁻⁷ + 0 + 0 0 0 0 0 0 0 0 0 00 0 0 10⁻⁸ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 TCID₅₀/100 μL 10^(7.00)10^(6.25) ≤10^(1.50) ≤10^(1.50) Percent Reduction ≥99.9997% ≥99.998% LogReduction 5.50 log₁₀ 4.75 log₁₀ (+) = positive test tor the presence oftest virus (0) = no test virus recovered and/or no cytotoxicity present

TABLE 5 PL-10 Cytotoxicity and Neutralization Results for HSV-2Cytotoxicity Control Neutralization Control Dilution PL-10 HSV-2 + PL-10Cell Control 0 0 0 0 0 0 0 0 10⁻² 0 0 0 0 + + + + 10⁻³ 0 0 0 0 + + + +10⁻⁴ 0 0 0 0 + + + + TCID₅₀/100 μL ≤10^(1.50) *Neutralized at ≤1.50Log₁₀ (+) = positive test for the presence of test virus (0) = no testvirus recovered and/or no cytotoxicity present *Neutralization controlreported as TCID₅₀/100 μL

Example 4 Efficacy of Personal Lubricant Against HBV in Suspension

The following example shows the results of the efficacy of the personallubricant against HBV in suspension.

HBV was evaluated in a virucidal suspension assay. The test medium wasLeibovitz L-15 medium supplemented with 0.1% glucose, 10 μMdexamethasone, 10 μg/mL insulin, 20 mM HEPES, 100 units/mL penicillin,and 10 μg/mL gentamicin. HBV was exposed to the personal lubricantformulation. At a pre-determined exposure time, an aliquot was removed,neutralized by serial dilution, and assayed for the presence of virus.The virus controls, cytotoxicity control, and neutralization controlwere assays in parallel. Antiviral properties of the personal lubricantwere evaluated and compared at the specified concentrations and timeintervals.

Duck HBV was exposed to a personal lubricant formulation, PL-10. Theexposure time was of either 5 minutes or 10 minutes at a temperature of20.0° C. in the presence of 100% duck serum, with no additional soilload added. PL-10 demonstrated a greater than 99.999% reduction in viraltiter following 5 minute exposure time and a greater than 99.998%reduction in viral titer following a 10 minute exposure time to duckHBV, as compared to the titer of the corresponding virus control. Thelog reductions in viral titer were greater than 5.00 log₁₀ and greaterthan 4.75 log₁₀, respectively. Table 6 summarizes the effects ofexposure of the personal lubricant to a suspension of HSV-2. Thecytotoxicity and neutralization control results are presented in Table7. Primary duck hepatocytes were used as indicator cell cultures.

TABLE 6 Effects of PL-10 Against HBV in Suspension Virus Control HBV +PL-10 5 minute 10 minute 5 minute 10 minute Dilution exposure exposureexposure exposure Cell Control 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 010⁻² + + + + + + + + 0 0 0 0 0 0 0 0 10⁻³ + + + + + + + + 0 0 0 0 0 0 00 10⁻⁴ + + + + + + + + 0 0 0 0 0 0 0 0 10⁻⁵ + + + + + + + + 0 0 0 0 0 00 0 10⁻⁶ + + + + + + + 0 0 0 0 0 0 0 0 0 10⁻⁷ 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 TCID₅₀/250 μL 10^(6.50) 10^(6.25) ≤10^(1.50) ≤10^(1.50) PercentReduction ≥99.999% ≥99.998% Log Reduction ≥5.00 log₁₀ ≥4.75 log₁₀ (+) =positive test for the presence of test virus (0) = no test virusrecovered and/or no cytotoxicity present

TABLE 7 PL-10 Cytotoxicity and Neutralization Results for HBVCytotoxicity Control Neutralization Control Dilution PL-10 HBV + PL-10Cell Control 0 0 0 0 0 0 0 0 10⁻² 0 0 0 0 + + + + 10⁻³ 0 0 0 0 + + + +10⁻⁴ 0 0 0 0 + + + + TCID₅₀/250 μL ≤10^(1.50) *Neutralized at ≤1.50Log₁₀ (+) = positive test for the presence of test virus (0) = no testvirus recovered and/or no cytotoxicity present *Neutralization controlreported as TCID₅₀/250 μL

Example 5 Efficacy of Personal Lubricant Against Chlamydia in Suspension

The following example shows the results of the efficacy of the personallubricant against Chlamydia trachomatis in suspension.

Chlamydia trachomatis was evaluated in a chlamydial suspension assay.The test medium was MEM supplemented with 10% (v/v) heat-inactivatedFBS, 2 μg/mL cycloheximide, 4.5 g/L glucose, 10 mM HEPES, 10 μg/mLgentamicin, and 2.5 μg/mL amphotericin B. A suspension of chlamydia wasexposed to the personal lubricant formulation. At a pre-determinedexposure time, an aliquot was removed, neutralized by serial dilution,and assayed for the presence of chlamydia. The chlamydia controls,cytotoxicity control, and neutralization control were assays inparallel. Antichlamydia properties of the personal lubricant wereevaluated and compared at the specified concentrations and timeintervals.

Chlamydia trachomatis (Serotype K), ATCC VR-887, strain UW-31/Cx wasexposed to a personal lubricant formulation, PL-10. The exposure timewas of either 5 minutes or 10 minutes at a temperature of 20.0° C. inthe presence of 5% FBS organic soil load. PL-10 demonstrated a greaterthan 99.999% reduction in chlamydia titer following 5 minute exposuretime and a greater than 99.998% reduction in chlamydia titer following a10 minute exposure time to Chlamydia trachomatis (Serotype K), ascompared to the titer of the corresponding Chlamydia control. The logreductions in chlamydia titer were greater than 5.00 log₁₀ and greaterthan 4.75 log₁₀, respectively. Table 8 summarizes the effects ofexposure of the personal lubricant to a suspension of chlamydia. Thecytotoxicity and neutralization control results are presented in Table9. McCoy indicator cell cultures were used.

TABLE 8 Effects of PL-10 Against Chlamydia in Suspension ChlamydiaControl Chlamydia trachomatis + PL-10 5 minute 10 minute 5 minute 10minute Dilution exposure exposure exposure exposure Cell Control 0 0 0 00 0 0 0 0 0 0 0 0 0 0 0 10⁻² + + + + + + + + 0 0 0 0 0 0 0 010⁻³ + + + + + + + + 0 0 0 0 0 0 0 0 10⁻⁴ + + + + + + + + 0 0 0 0 0 0 00 10⁻⁵ + + + + + + + + 0 0 0 0 0 0 0 0 10⁻⁶ + + + + + + 0 + 0 0 0 0 0 00 0 10⁻⁷ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 TCID₅₀/200 μL 10^(6.50)10^(6.25) ≤10^(1.50) ≤10^(1.50) Percent ≥99.999% ≥99.998% Reduction LogReduction ≥5.00 log₁₀ ≥4.75 log₁₀ (+) = positive test for the presenceof test chlamydia (0) = no test chlamydia recovered and/or nocytotoxicity present

TABLE 9 PL-10 Cytotoxicity and Neutralization Results for ChlamydiaCytotoxicity Control Neutralization Control Dilution PL-10 Chlamydiatrachomatis + PL-10 Cell Control 0 0 0 0 0 0 0 0 10⁻² 0 0 0 0 + + + +10⁻³ 0 0 0 0 + + + + 10⁻⁴ 0 0 0 0 + + + + TCID₅₀/100 μL ≤10^(1.50)*Neutralized at ≤1.50 Log₁₀ (+) = positive test for the presence of testchlamydia (0) = no test chlamydia recovered and/or no cytotoxicitypresent *Neutralization control reported as TCID₅₀/200 μL

Example 6 Efficacy of Personal Lubricant Against Neisseria gonorrhoeaein Suspension

The following example shows the results of the efficacy of the personallubricant against Neisseria gonorrhoeae in suspension.

Neisseria gonorrhoeae was evaluated in a time kill assay. The test wasconducted in an agar plate medium of chocolate agar. Neisseriagonorrhoeae, ATCC 43069, was exposed to a personal lubricantformulation, PL-10 at exposure times of 1, 2, 5, and 10 minutes insuspension at a temperature of 21.0° C. After exposure, an aliquot ofthe suspension was transferred to a neutralizer and was assayed forsurvivors. Appropriate culture purity, neutralizer sterility, testpopulation, and neutralization confirmation controls were performed. Theneutralizer was Letheen broth with 0.07% lecithin and 0.5% Tween 80.

The neutralizer sterility control shows no growth of Neisseriagonorrhoeae. The control population of Neisseria gonorrhoeae shows3.2×10⁴ colony forming units, and log reduction of 4.51 log₁₀. Theexposure of Neisseria gonorrhoeae to PL-10 for any of 1, 2, 5, and 10minutes showed no survivors at any of the dilution. Table 10 summarizesthe effects of exposure for PL-10 against Neisseria gonorrhoeae.

TABLE 10 PL-10 Against Neisseria gonorrhoeae CFU/mL in Test Exposurepopulation Time control CFU/mL of Log₁₀ Percent Log₁₀ (minutes) (Log₁₀)Survivors Survivors Reduction Reduction 1 3.2 × 10⁴ <5<0.70 >99.9% >3.81 2 (4.51) <5 <0.70 >99.9% >3.81 5 <5<0.70 >99.9% >3.81 10 <5 <0.70 >99.9% >3.81 CFU = colony forming units

Table 11 summarizes the results of Examples 2-6 for the efficacy ofPL-10 in reducing a variety of organismal populations.

TABLE 11 PL-10 Destroys Major Sexually Transmitted Infections MaxPopulation at Population at Test Control 5 minute Percent 10 minutePercent Organism Population exposure Reduction exposure Reduction HIV-14.00 Log₁₀ 0 >99.99% 0 >99.99% Herpes 5.50 Log₁₀ 0 >99.9997% 0 >99.998%simplex virus type 2 Hepatitis 5.00 Log₁₀ 0 >99.999% 0 >99.998% B virusChlamydia 5.00 Log₁₀ 0 >99.999% 0 >99.998% trachomatis Neisseria  3.8Log₁₀ 0 >99.9% 0 >99.9% gonorrhoeae

Example 7 Cytotoxicity of Personal Lubricant on Cell Culture

The following example shows the results of the cytotoxicity of thepersonal lubricant on cell cultures.

The personal lubricant PL-10 was added to mouse fibroblast cells andincubated for 24 hours. The cells were observed under 100× magnificationand the amount of morphology was scored using a 0-4 scale, where 0=noreactivity and 4=severe reactivity. A score of 3 or greater indicates acytotoxic effect. The personal lubricant received a score of 2,indicating that the personal lubricant is not cytotoxic on mousefibroblast cultures.

Example 8 Sensitivity Test of Personal Lubricant

The following example shows the results of the sensitivity of thepersonal lubricant on animal models.

The personal lubricant was tested on guinea pigs to determine ifexposure to the product produced a delayed-type hypersensitivity skinreaction. In this example, guinea pigs were exposed to the personallubricant and to a control substance both underneath the skin andtopically. After 14 days, the animals were again exposed to thelubricant or control. The test sites on the skin were evaluated at both24 and 48 hours post treatment. No sensitization reactions wereobserved, and the test group did not exhibit differences from thecontrol group.

Example 9 Vaginal Mucosal Irritation Test of Personal Lubricant

The following example shows the results of the personal lubricant onvaginal mucosal irritation. The personal lubricant of Example 1, PL-10,was used on rabbits to determine the effects of the personal lubricanton vaginal tissue. The study complied with all applicable sections ofthe Final Rules of the Animal Welfare Act regulations (9 CFR 1-3), thePublic Health Service Policy on Humane Care and Use of LaboratoryAnimals, and the Guide for the Care and Use of Laboratory Animals. Testprocedures were reviewed and approved by PBL's Institutional Animal Careand Use Committee (IACUC) in compliance with Animal Welfare Act.

Environment. New Zealand white rabbits were housed individually instainless steel cages. Animals were maintained in a controlledenvironment at a nominal temperature range of 16 to 22° C., a humidityrange of 50 to 20%, and a light/dark cycle of 12 hours. Animals weremaintained in rooms with at least ten room air changes per hour.

Diet and Feed. Animals received a Certified Laboratory Rabbit Dietapproximately 165 g per day. The feed is analyzed by the supplier fornutritional components and environmental contaminants. There are noknown contaminants in the feed that interfered with the conduct of thisexample.

Water. Fresh, potable drinking water was provided ad libitum to allanimals via a sipper tube. Water testing is conducted two times a yearfor total dissolved solids and specified microbiological content andselected elements, heavy metals, organophosphates, and chlorinatedhydrocarbons. There are no known contaminants in the water thatinterfered with the conduct of this example.

Acclimation. Animals placed on study were acclimated to the testingfacility for at least 6 days prior to initiation of the study. Healthobservations were performed prior to the study to ensure that theanimals were acceptable for study use.

Assignment to Study and Disposition. Animals were examined prior tostudy initiation, and determined (based on clinical observations)suitable as test subjects.

Test and Control Article Preparation: The personal lubricant PL-10 isapplied. Physiological saline (SCI) is used as a negative control.

Procedure: Six female rabbits were used in this example (three test andthree control animals). Prior to the test and prior to each treatment,the animals were checked for vaginal discharge, swelling and/or otherevidence of vaginal infection, irritation or injury. The animals wereweighed prior to the initial dosing and at the termination of the test.Rabbits were dosed at 24±2 hour intervals every day for a minimum offive consecutive days (Days 0, 1, 2, 3 and 4). A short, soft catheter(approximately 6 cm) or blunt-tipped cannula (for example, 12 FrenchNelaton catheter) attached to a syringe was used for administration ofthe personal lubricant. The dose volume was approximately 1 mL. The tipof the catheter used for the test group animals was moistened with thepersonal lubricant and inserted into vagina. The tip of the catheterused for the control group animals was moistened with a controllubricant (for example, Lubrivet) and inserted into the vagina. Thepersonal lubricant or control (at least 1 mL) was introduced no morethan 6 cm into the anterior vagina. Any expelled material was gentlyremoved with a soft tissue and rabbit returned to its cage.

Clinical Observation: At 24 ±2 hours after the initial application andimmediately prior to each treatment, the appearance of the vaginalopening and perineum was noted for signs of discharge, erythema andedema. At 24 ±2 hours after the last dose, all animals were euthanized.The entire urogenital tract (including the vagina and the cervix) wasremoved. The entire vagina was opened longitudinally, and examined forgross evidence of irritation, injury to epithelial layer of tissue andnecrosis. The entire urogenital tract was placed in 10% formalin andsamples further processed by approved histopathology laboratory (forexample, HSRL, VA). Histopathological evaluation of tissues wasperformed by a Board Certified Pathologist. The vaginal tissues wereevaluated for the irritant effects.

Results: No evidence of mucosal irritation was found in the test animalsfollowing vaginal exposure to the personal lubricant, based on bothmacroscopic (evidence of irritation, epithelial cell injury, andnecrosis) and microscopic (histopathological) analysis.

Example 10 Acute Systemic Toxicity of Personal Lubricant

The following example shows that the personal lubricant described hereindoes not show systemic toxicity in mice.

Mice were injected intraperitoneally with the personal lubricant andobserved for 3 days. None of the animals tested exhibited any biologicalreactivity during the test period, including no difference in bodyweight, no signs of dehydration, no abnormal posture or appearance ofskin, eyes, fur and mucous membranes, no change in urine and fecaloutput, and no change in locomotor behavior.

Example 11 Condom Compatibility of Personal Lubricant

The following example demonstrates that the personal lubricant asdescribed herein is compatible with a variety of condoms in terms ofbeing compatible with standard condom testing measures, such as burstpressure, burst volume, break force, and elongation.

The personal lubricant was tested with latex, polyisoprene, andpolyurethane condoms. As a baseline, each condom was tested as received,with no heat or lubricant applied. A control was performed with eachcondom exposed to 40° C. for 1 hour, without lubricant. A positivecontrol was performed with each condom exposed to 40° C. for 1 hour withmineral oil applied. The test was performed at 40° C. for 1 hour withthe personal lubricant, PL-10. Test results indicate that the personallubricant passed all natural latex and polyisoprene condom compatibilitytesting.

In at least some of the previously described embodiments, one or moreelements used in an embodiment can interchangeably be used in anotherembodiment unless such a replacement is not technically feasible. Itwill be appreciated by those skilled in the art that various otheromissions, additions and modifications may be made to the methods andstructures described above without departing from the scope of theclaimed subject matter. All such modifications and changes are intendedto fall within the scope of the subject matter, as defined by theappended claims.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (for example, bodiesof the appended claims) are generally intended as “open” terms (forexample, the term “including” should be interpreted as “including butnot limited to,” the term “having” should be interpreted as “having atleast,” the term “includes” should be interpreted as “includes but isnot limited to,” etc.). It will be further understood by those withinthe art that if a specific number of an introduced claim recitation isintended, such an intent will be explicitly recited in the claim, and inthe absence of such recitation no such intent is present. For example,as an aid to understanding, the following appended claims may containusage of the introductory phrases “at least one” and “one or more” tointroduce claim recitations. However, the use of such phrases should notbe construed to imply that the introduction of a claim recitation by theindefinite articles “a” or “an” limits any particular claim containingsuch introduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (for example, “a” and/or “an” should be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould be interpreted to mean at least the recited number (for example,the bare recitation of “two recitations,” without other modifiers, meansat least two recitations, or two or more recitations). Furthermore, inthose instances where a convention analogous to “at least one of A, B,and C, etc.” is used, in general such a construction is intended in thesense one having skill in the art would understand the convention (forexample, “a system having at least one of A, B, and C” would include butnot be limited to systems that have A alone, B alone, C alone, A and Btogether, A and C together, B and C together, and/or A, B, and Ctogether, etc.). In those instances where a convention analogous to “atleast one of A, B, or C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (for example, “a system having at least one of A, B, orC” would include but not be limited to systems that have A alone, Balone, C alone, A and B together, A and C together, B and C together,and/or A, B, and C together, etc.). It will be further understood bythose within the art that virtually any disjunctive word and/or phrasepresenting two or more alternative terms, whether in the description,claims, or drawings, should be understood to contemplate thepossibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

In addition, where features or aspects of the disclosure are describedin terms of Markush groups, those skilled in the art will recognize thatthe disclosure is also thereby described in terms of any individualmember or subgroup of members of the Markush group.

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible sub-rangesand combinations of sub-ranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal halves, thirds, quarters, fifths,tenths, etc. As a non-limiting example, each range discussed herein canbe readily broken down into a lower third, middle third and upper third,etc. As will also be understood by one skilled in the art all languagesuch as “up to,” “at least,” “greater than,” “less than,” and the likeinclude the number recited and refer to ranges which can be subsequentlybroken down into sub-ranges as discussed above. Finally, as will beunderstood by one skilled in the art, a range includes each individualmember. Thus, for example, a group having 1-3 articles refers to groupshaving 1, 2, or 3 articles. Similarly, a group having 1-5 articlesrefers to groups having 1, 2, 3, 4, or 5 articles, and so forth.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

1. (canceled)
 2. A lubricant, comprising: an electrolyzed salinesolution; a rheology modifier; and a polymeric organosilicon compound.3. The lubricant of claim 2, wherein the saline solution comprisessodium chloride present in an amount of about 0.1% to about 0.4% w/v. 4.The lubricant of claim 2, wherein the sodium chloride is present in anamount of about 0.28% w/v.
 5. The lubricant of claim 2, wherein theelectrolyzed saline solution comprises hypochlorite present in an amountof about 10 to about 300 ppm.
 6. The lubricant of claim 2, wherein thepolymeric organosilicon compound is dimethicone.
 7. The lubricant ofclaim 2, wherein the polymeric organosilicon compound is present in anamount of about 0.5% to about 50% w/v.
 8. The lubricant of claim 2,wherein the polymeric organosilicon compound is present in an amount ofabout 10% w/v.
 9. The lubricant of claim 2, wherein the rheologymodifier comprises a metal silicate.
 10. The lubricant of claim 2,wherein the rheology modifier is present in an amount of about 0.1% toabout 15% w/v.
 11. The lubricant of claim 2, wherein the rheologymodifier is present in an amount of about 3.25% w/v.
 12. The lubricantof claim 2, further comprising a buffer or water
 13. The lubricant ofclaim 12, wherein the buffer is present in an amount of about 0.05% toabout 15% w/v.
 14. A method of making a lubricant, comprising:electrolyzing a saline solution to generate a solution comprisinghypochlorite; providing a polymeric organosilicon compound; and mixingthe solution comprising hypochlorite with the polymeric organosiliconcompound to form a lubricant.
 15. The method of claim 14, wherein thesaline solution comprises sodium chloride present in an amount of about0.1% to about 0.4% w/v.
 16. The method of claim 14, wherein thepolymeric organosilicon compound is present in an amount of about 0.5%to about 50% w/v.
 17. The method of claim 14, further comprising mixingthe lubricant with a rheology modifier.
 18. The method of claim 17,wherein the rheology modifier is a metal silicate.
 19. The method ofclaim 18, wherein the metal silicate is sodium magnesium silicate. 20.The method of claim 14, wherein the hypochlorite is present in an amountranging from about 10 to about 300 ppm.
 21. The method of claim 14,further comprising mixing the lubricant with water.